BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OASYS POLYAXIAL SCREW CANCELLOUS DIA 3.5 X 16

    MDR report key: 2864601 · Received December 6, 2012

    Report

    Report Number
    9617544-2012-00548
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 8, 2012
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    NKB
    PMA / PMN Number
    K072568
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL. METHOD, RESULT AND CONCLUSION WILL BE MADE AVAILABLE FOLLOWING AN ENGINEERING EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "SURGEON WAS DRIVING IN SCREWS AND THEY STRIPPED OUT. SCREWS WERE THEN REMOVED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OASYS POLYAXIAL SCREW CANCELLOUS DIA 3.5 X 16 IMPLANT NKB STRYKER SPINE BORDEAUX NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK